Common use of Notification of Threatened Action Clause in Contracts

Notification of Threatened Action. Each Party will immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority, which may affect the safety or efficacy claims of any Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 7 contracts

Samples: License and Collaboration Agreement (Zai Lab LTD), License and Collaboration Agreement (Zai Lab LTD), License and Collaboration Agreement (NovoCure LTD)

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Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority, which may affect the safety or efficacy claims of any Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will shall promptly consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 6 contracts

Samples: , Development and Commercialization Agreement (Revolution Medicines, Inc.), , Development and Commercialization Agreement (Revolution Medicines, Inc.), License and Collaboration Agreement (Cytokinetics Inc)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including a Regulatory Authority, which may materially affect the safety Development, Commercialization or efficacy claims regulatory status of any Licensed Product a Product, whether in or outside the continued marketing of any Licensed ProductTerritory. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 5 contracts

Samples: Development and Commercialization Agreement (Fibrogen Inc), License, Development and Commercialization Agreement, Development and Commercialization Agreement (Fibrogen Inc)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority against itself, its Affiliates, or any of its subcontractors or sublicensees (including any Persons in the supply or distribution chain of the Product) as well as any Regulatory Authority, which may materially affect the safety Development, Commercialization or efficacy claims regulatory status of any Licensed a Product or in the continued marketing of any Licensed ProductTerritory. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 4 contracts

Samples: License and Collaboration Agreement (Menlo Therapeutics, Inc.), License and Collaboration Agreement (Menlo Therapeutics, Inc.), License and Collaboration Agreement (Menlo Therapeutics, Inc.)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including a Regulatory Authority, which may affect the safety Development, Commercialization or efficacy claims regulatory status of any Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 3 contracts

Samples: License, Development and Commercialization Agreement (Spectrum Pharmaceuticals Inc), License, Development and Commercialization Agreement (Allos Therapeutics Inc), License, Development and Commercialization Agreement (Allos Therapeutics Inc)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority, which may affect the safety or efficacy claims of any Licensed the Product or the continued marketing of any Licensed the Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 3 contracts

Samples: License and Collaboration Agreement (Five Prime Therapeutics Inc), License and Collaboration Agreement (Five Prime Therapeutics Inc), License and Collaboration Agreement (Five Prime Therapeutics Inc)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority, which may affect the safety or efficacy claims of any Licensed Collaboration Product or the continued marketing of any Licensed Collaboration Product. Upon receipt of such information, the Parties will shall promptly consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 3 contracts

Samples: License and Collaboration Agreement (Cytokinetics Inc), License and Collaboration Agreement (Cytokinetics Inc), License and Collaboration Agreement (Cytokinetics Inc)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including a Regulatory Authority, which may materially affect the safety Development, Commercialization or efficacy claims regulatory status of any Licensed a Product or in the continued marketing of any Licensed ProductTerritory. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 3 contracts

Samples: Development and Commercialization Agreement (Fibrogen Inc), Fibrogen Inc, Development and Commercialization Agreement (Fibrogen Inc)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including a Regulatory Authority, which may materially affect the safety Development, Commercialization or efficacy claims regulatory status of any Licensed Product or the continued marketing of any a Licensed Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 3 contracts

Samples: License, Marketing and Development Agreement (Alliqua, Inc.), License, Marketing and Development Agreement (Celgene Corp /De/), License, Marketing and Development Agreement (Celgene Corp /De/)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Regulatory Authority, which may affect the safety Commercialization or efficacy claims Regulatory Approval of any Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 2 contracts

Samples: License and Services Agreement (Jaguar Health, Inc.), License and Services Agreement (Jaguar Health, Inc.)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including a Regulatory Authority, which may affect the safety Development, Commercialization or efficacy claims regulatory status of any Licensed Product or the continued marketing of any Licensed a Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 2 contracts

Samples: License, Development and Commercialization Agreement (Windtree Therapeutics Inc /De/), License, Development and Commercialization Agreement (Windtree Therapeutics Inc /De/)

Notification of Threatened Action. Each Party will shall immediately notify the other Party (including by providing notice to the other Party’s Alliance Manager) of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including without limitation a Regulatory Authority, which may affect the safety Development, Manufacture, Commercialization or efficacy claims regulatory status of any Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 2 contracts

Samples: Collaboration and License Agreement (Inovio Pharmaceuticals, Inc.), Collaboration and License Agreement (Inovio Pharmaceuticals, Inc.)

Notification of Threatened Action. Each Party will immediately shall notify the other Party within [ * ] of any information it receives regarding any threatened or pending action, inspection inspection, or communication by any Regulatory Authority, which may affect the safety or efficacy claims of any Licensed Product or the continued marketing Development or Commercialization of any Licensed Product. Upon receipt of such information, the Parties will shall promptly consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 2 contracts

Samples: Collaboration and License Agreement (Exelixis, Inc.), Collaboration and License Agreement (Exelixis, Inc.)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including without limitation a Regulatory Authority, which may affect the safety development, manufacture, commercialization or efficacy claims of any Licensed Product or the continued marketing regulatory status of any Licensed Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 2 contracts

Samples: Collaboration and License Agreement (Kempharm, Inc), License, Development and Commercialization Agreement (Synergy Pharmaceuticals, Inc.)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority, which may affect the safety or efficacy claims of any Licensed Product or the continued marketing of any Licensed ProductProduct in the Field. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 2 contracts

Samples: License and Collaboration Agreement (Signal Genetics, Inc.), License and Collaboration Agreement (Signal Genetics, Inc.)

Notification of Threatened Action. Each Party will immediately shall promptly notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including a Regulatory Authority, which may materially affect the safety Development, Manufacturing, Commercialization or efficacy claims regulatory status of any Licensed Product or the continued marketing of any a Licensed Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking coordinate, to the extent reasonably necessary on appropriate action.

Appears in 2 contracts

Samples: License and Collaboration Agreement (Molecular Partners Ag), License and Collaboration Agreement (Allergan Inc)

Notification of Threatened Action. Each Party will shall immediately notify the other Party in writing of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including a Regulatory Authority, which may affect the safety Development, commercialization or efficacy claims regulatory status of any Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 2 contracts

Samples: Exclusive License and Commercialization Agreement (Therapeutics Acquisition Corp.), Exclusive License and Commercialization Agreement (Therapeutics Acquisition Corp.)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any party, including, without limitation, a Regulatory Authority, Authority which may affect the safety or efficacy claims of any Licensed the A1PI IV Product or the continued marketing of any Licensed the A1PI IV Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 2 contracts

Samples: Technology License Agreement (Kamada LTD), Technology License Agreement (Kamada LTD)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Regulatory Authority, which may affect the safety Development, Commercialization or efficacy claims Regulatory Approval of any Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 2 contracts

Samples: License Agreement (Jaguar Health, Inc.), License Agreement (Jaguar Health, Inc.)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including a Regulatory Authority, which may materially affect the safety Development, Commercialization or efficacy claims regulatory status of any Licensed Product or the continued marketing of any Licensed a Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action. If ITI and Takeda are not able to agree on the procedure, Takeda shall have the right to decide the appropriate action.

Appears in 2 contracts

Samples: License and Collaboration Agreement (Intra-Cellular Therapies, Inc.), License and Collaboration Agreement (Intra-Cellular Therapies, Inc.)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including, without limitation, a Regulatory Authority, Authority which may affect the safety or efficacy claims of any Licensed the Product or the continued marketing Commercialization of any Licensed the Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 2 contracts

Samples: Exclusive Distribution Agreement (Kamada LTD), Exclusive Distribution Agreement (Kamada LTD)

Notification of Threatened Action. Each Party will Throughout the duration of this Agreement and with respect to all Licensed Products, the Parties shall immediately notify the each other Party of any information it a Party receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority, or from a concerned Competent Authority which may affect the safety or efficacy claims of any the Licensed Product Products or the continued marketing of any the Licensed Product. Upon receipt of such information, the Parties will consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate actionProducts.

Appears in 2 contracts

Samples: License and Development Agreement (Collegium Pharmaceutical, Inc), License and Development Agreement (Biodelivery Sciences International Inc)

Notification of Threatened Action. Each Party will shall immediately (but in any event no later than [***]) notify the other Party (including by providing notice to the other Party’s Alliance Manager) of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including without limitation a Regulatory Authority, which may affect the safety Development, Manufacture, Commercialization or efficacy claims of any Licensed Product or the continued marketing regulatory status of any Licensed Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 2 contracts

Samples: Collaboration and License Agreement (Spruce Biosciences, Inc.), Collaboration and License Agreement (Aravive, Inc.)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any party, including, without limitation, a Regulatory Authority, which may affect the safety or efficacy claims of any Licensed a Product or the continued marketing of any Licensed a Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 2 contracts

Samples: Development and Commercialization Agreement, And Commercialization Agreement (Ampio Pharmaceuticals, Inc.)

Notification of Threatened Action. Each Party will immediately shall notify the other Party within [ * ] of any information it receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority, which may affect the safety or efficacy claims of any Licensed Product or the continued marketing Development or Commercialization of any Licensed Product. Upon receipt of such information, the Parties will shall promptly consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 2 contracts

Samples: Collaboration and License Agreement (Exelixis, Inc.), Collaboration and License Agreement (Exelixis, Inc.)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Person, including, without limitation, a Regulatory Authority, which may affect the safety or efficacy claims of any Licensed a Product or the continued marketing of any Licensed a Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 2 contracts

Samples: Research Services Agreement (Dyadic International Inc), Research Services Agreement (Dyadic International Inc)

Notification of Threatened Action. Each Party will immediately shall notify the other Party as soon as practicable of any information it receives regarding any threatened notice from a Regulatory Authority having jurisdiction in its territory, that relates to an impending action or pending actioninspection, inspection or communication by any Regulatory Authority, which may and that would reasonably be expected to adversely affect the safety or efficacy claims of any Licensed the Product or the continued marketing of any Licensed the Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking agree an appropriate actionresponse.

Appears in 2 contracts

Samples: License and Collaboration Agreement, License and Collaboration Agreement (Visterra, Inc.)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority, which may is reasonably likely affect the safety or efficacy claims of any Licensed Compound or Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will shall promptly consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: Collaboration and License Agreement (IGM Biosciences, Inc.)

Notification of Threatened Action. Each Party will shall immediately notify the other Party (including by providing notice to the other Party’s Alliance Manager) of any information it receives regarding any threatened or pending action, inspection inspection, or communication by or from any Third Party, including without limitation a Regulatory Authority, which may affect the safety Development, Manufacture, Commercialization, or efficacy claims of any Licensed Product or the continued marketing regulatory status of any Licensed Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: License Agreement (Keros Therapeutics, Inc.)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including a Regulatory Authority, which may affect the safety Development, Commercialization or efficacy claims regulatory status of any Licensed Product or the continued marketing of any a Licensed Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: License and Collaboration Agreement (Savara Inc)

Notification of Threatened Action. Each Party will immediately shall promptly and, in any event within thirty (30) days, notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Regulatory Authoritythird party, including without limitation a regulatory authority, which may materially affect the safety development, commercialization or efficacy claims regulatory status of any a Licensed Product or in the continued marketing of any Licensed ProductField in the Territory. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: Exclusive License Agreement (Brooklyn ImmunoTherapeutics, Inc.)

Notification of Threatened Action. Each Party will immediately shall notify the other Party within [***] of any information it receives regarding any threatened or pending action, inspection inspection, or communication by any Regulatory Authority, Authority which may affect the safety or efficacy claims of any Licensed Product or the continued marketing Development or Commercialization of any Licensed Product. Upon receipt of such information, the Parties will shall promptly consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: Exclusive License and Collaboration Agreement (Forty Seven, Inc.)

Notification of Threatened Action. Each Party will party shall immediately notify the other Party party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Regulatory Authorityparty, including, without limitation, a regulatory authority which may affect the safety or efficacy claims of any Licensed the Product or the continued marketing of any Licensed the Product. Upon receipt of such information, the Parties will parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: Distribution Agreement (Kamada LTD)

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Notification of Threatened Action. Each Party will immediately shall [*] notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including without limitation a Regulatory Authority, which may affect the safety Development, Manufacture, Commercialization or efficacy claims regulatory status of any Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: License and Collaboration Agreement (C4 Therapeutics, Inc.)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority, which may materially affect the safety or efficacy claims of any Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: License Agreement (vTv Therapeutics Inc.)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Regulatory Authoritythird party, including any Agency, which may materially affect the safety development, Promotion or efficacy claims regulatory status of any Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: Distribution and Supply Agreement (Misonix Inc)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including without limitation a Regulatory Authority, which may affect the safety Development, Manufacture, Commercialization or efficacy claims regulatory status of any Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: Development and Manufacturing Collaboration Agreement (Vir Biotechnology, Inc.)

Notification of Threatened Action. Each Party will party shall immediately notify the other Party party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Regulatory Authorityparty, including, without limitation, a Governmental Health Authority which may affect the safety or efficacy claims of any Licensed the Product or the continued marketing of any Licensed the Product. Upon receipt of such information, the Parties will parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action. Ivivi shall bear all costs and expenses associated with taking such action.

Appears in 1 contract

Samples: Exclusive Distribution Agreement (Ivivi Technologies, Inc.)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any party, including, without limitation, a Regulatory Authority, which may affect the safety or efficacy claims of any Licensed a Product or the continued marketing of any Licensed a Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.. License, Development and Commercialization Agreement between Ampio and Daewoong

Appears in 1 contract

Samples: License, Development (Aytu Bioscience, Inc)

Notification of Threatened Action. Each Party will shall immediately notify the other Party (including by providing notice to the other Party’s Alliance Manager) of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including without limitation a Regulatory Authority, which may affect the safety Development, Manufacture, Commercialization or efficacy claims of any Licensed Product or the continued marketing regulatory status of any Licensed Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: Collaboration and License (Glycomimetics Inc)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including without limitation a Regulatory Authority, which may adversely affect the safety development, manufacture, commercialization or efficacy claims of any Licensed Product or the continued marketing regulatory status of any Licensed Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: License, Development and Commercialization Agreement (Aridis Pharmaceuticals, Inc.)

Notification of Threatened Action. Each Party will immediately shall notify the other Party within [ ] ([ ]) [ ] of any information it receives regarding any threatened or pending action, inspection inspection, or communication by any Regulatory Authority, Authority which may adversely affect the safety or efficacy claims of any Licensed Product or the continued marketing Development, manufacture, or Commercialization of any Licensed Product. Upon receipt of such information, the Parties will shall promptly consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: License Agreement (Eyenovia, Inc.)

Notification of Threatened Action. Each Party will immediately shall notify the other Party within [ * ] of any information it receives regarding any threatened or pending action, inspection inspection, or communication by any Regulatory Authority, Authority which may adversely affect the safety or efficacy claims of any Licensed Product or the continued marketing Development or Commercialization of any Licensed Product. Upon receipt of such information, the Parties will shall promptly consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: License Agreement (Rigel Pharmaceuticals Inc)

Notification of Threatened Action. Each Party will shall immediately notify the other Party (including by providing notice to the other Party’s Alliance Manager) of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including a Regulatory Authority, which may affect the safety or efficacy claims of any Licensed Product or the continued marketing of any Licensed Producthas an Adverse Risk. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: License Agreement (Menlo Therapeutics Inc.)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including a Regulatory Authority, which may materially affect the safety Development, Commercialization or efficacy claims regulatory status of any Licensed Product or the continued marketing of any Licensed an Aradigm Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: License and Collaboration Agreement (Aradigm Corp)

Notification of Threatened Action. Each Party will immediately shall notify the other Party within twenty-four (24) hours of any information it receives regarding any threatened or pending action, inspection inspection, or communication by any Regulatory Authority, Authority which may affect the safety or efficacy claims of any Licensed Product or the continued marketing Development or Commercialization of any Licensed Product. Upon receipt of such information, the Parties will shall promptly consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: Collaboration and License Agreement (Ovid Therapeutics Inc.)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including a Regulatory Authority, which may materially affect the safety Commercialization or efficacy claims regulatory status of any Licensed Product or the continued marketing of any a Licensed Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: License and Marketing Agreement (SANUWAVE Health, Inc.)

Notification of Threatened Action. Each Party will immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority, which may affect the safety or efficacy claims of any Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: License Agreement (vTv Therapeutics Inc.)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including a Regulatory Authority, which may affect the safety Development, manufacturing, Commercialization or efficacy claims regulatory status of any the Licensed Compound or a Product or the continued marketing of any Licensed Productin their respective territory. Upon receipt of such information, the Parties will shall convene a JSC meeting and otherwise consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: Co Development and Manufacturing Agreement (Prometheus Biosciences, Inc.)

Notification of Threatened Action. Each Party will immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including a Regulatory Authority, which may affect the safety Development or efficacy claims regulatory status of any Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: Option and License Agreement (Exicure, Inc.)

Notification of Threatened Action. Each Throughout the duration of this Agreement, each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority, or from a concerned Governmental Authority which may affect the safety or efficacy claims of any Licensed the Product or the continued marketing of any Licensed the Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: Collaboration and License Agreement (Sonus Pharmaceuticals Inc)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including without limitation a Regulatory Authority, which may affect the safety Development, Commercialization or efficacy claims regulatory status of any Licensed Product or the continued marketing of any a Licensed Product. Upon Without prejudice to the other provisions set forth in this Agreement, upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: License, Development and Commercialization Agreement (Impax Laboratories Inc)

Notification of Threatened Action. Each Party will immediately shall notify the other Party of within [*], after receiving any information it receives regarding any threatened or pending action, inspection inspection, or communication by any Regulatory Authority, Authority which may adversely affect the safety or efficacy claims of any Licensed Product or the continued marketing Development or Commercialization of any Licensed Product. Upon receipt of such information, the Parties will shall promptly consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

Appears in 1 contract

Samples: Collaboration and License Agreement (Rigel Pharmaceuticals Inc)

Notification of Threatened Action. Each Party will shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including, without limitation, a Regulatory Authority, which may affect the safety or efficacy claims of any Licensed a Product or the continued marketing of any Licensed a Product. Upon receipt of such information, the Parties will shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.. AIT Therapeutics / Circassia License, Development and Commercialization Agreement

Appears in 1 contract

Samples: Confidential Treatment (AIT Therapeutics, Inc.)

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